Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according EU/OECD guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
(1997)
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strainopen allclose all
Species / strain / cell type:
E. coli WP2 uvr A
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
S9-mix
Test concentrations with justification for top dose:
The following doses per plate were evaluated:
test substance 5, 15.81, 50, 158.1, 500, 1581, 5000 μg per plate
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 4-nitro-1,2-phenylenediamine (TA 98), Sodium azide (TA 100, TA 1535), 9-aminoacridine (TA 1537), Methyl-methanesulfonate (E.coli WP2 uvrA), 2-aminoanthracene (TA 98, TA 100, TA 1535, TA 1537, E.coli WP2 uvrA, +S9-mix)

Results and discussion

Test resultsopen allclose all
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
at 5000 µg/plate for TA 100 and TA 1537 without S9-mix
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The Salmonella/microsome test, employing doses of up to 5000 ug per plate, showed the test substance does not produce bacteriotoxic effects with an exception at the highest dose level of 5000 µg per plate (without S-9 mix) in the TA 100 and TA 1537 tester strains. No indications of mutagenic effects of the test substance could be found at assessable doses of up to 5000 ug per plate in any of the Salmonella typhimurium and E.coli WP2 uvrA strains used. The test substance was considered to be non-mutagenic without and with S9-mix in the plate incorporation as well as in the pre-incubation modification of the Salmonella/microsome test.